GRiP Tools for Interoperability Questions and Considerations for - PowerPoint PPT Presentation

GRiP – Tools for Interoperability Questions and Considerations for Ethics Committees Evaluating Paediatric Drug Trials Allison Needham Anne Junker The Hospital for Sick Children in Collaboration with GRiP Partners

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Aims 1) To collect and evaluate available guidance on key issues identified by EC’s during the ethical evaluation of pediatric research. 2) Synthesize the appraised guidance to prepare a document outlining the specific questions that need answering and the considerations that should be made in the ethics review of paediatric clinical trial research GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Process 1) Invite experts – ethicists with ped expertise 2) Select 5 main ethics questions for pediatric drug trial ethics review 3) Collect guidance 4) Conduct content and quality appraisal of guidance 5) Synthesize guidance to prepare ‘layered’ document 6) Pilot tool and obtain feedback 7) Finalize tool and explanatory document GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Task Working Group • Francis Crawley – Executive Director, GCP Alliance • Robert “Skip” Nelson – Deputy Director and Senior Pediatric Ethicist, FDA • Hugh Davies – Paediatrician and National Ethics Advisor, NRES UK • Bobby Farsides – Professor of Clinical and Biomedical ethics and Chair, Nuffield Bioethics • Pau Ferrer - Professor of Bioethics, member of International GCP working group • Allison Needham , MSc supported by Martin Offringa , Professor of Pediatrics and Head, Child Health Evaluation Sciences Unit, Sick Kids Research Institute, Canada GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

What are the key pediatric specific questions that should be asked during the ethics review of a drug trial protocol? GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

GRiP – YPAG International consensus guidelines for the formation of young person advisory groups Winnie Chan Anne Junker The Hospital for Sick Children in Collaboration with GRiP Partners

Disclaimer • I am not a member of GRiP • I am not a member of this Task Working Group • I have not first-hand contributed content to the developing guidance  I do oversee a YPAG and the program guidance  I am involved in review and advice about the international consensus guideline and website GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Rationale for YPAG: Avoidance of Waste in the Production and Reporting of Research Evidence Iain Chalmers, Paul Glasziou Lancet 2009;374:86-89 . GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Aims 1) To develop guidance for ‘best practices’ to create Young Person Advisory Groups 2) To make this information broadly available GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Process 1) Invite the experts 2) Collect existing guidance from current YPAGs 3) Conduct content and quality appraisal of guidance 4) Synthesize guidance to prepare document and website 5) Pilot and obtain feedback 6) Launch! GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

Task Working Group • existing YPAGs – UK Clinical Research Network: Children Specialty – Scottish Children’s Research Network – Young Persons Advisory Group (YPAG), Vancouver, Canada – Kids and Families Impacting Disease Through Science (KIDS) of the American Academy of Pediatric (AAP) in the USA • Dr. Cor Oosterwijk, vice-president of the European Genetic Alliances' Network patient and public involvement expert, • many fellow GRiP members • Winnie Chan , MPH supported by Martin Offringa , Professor of Pediatrics and Head, Child Health Evaluation Sciences Unit, Sick Kids Research Institute, Canada GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060

This presentation reflects only the author(s)’s views and the Union is not liable for any use that may be made with the information contained therein. GRiP project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 261060